nbi-98854 for the treatment of tardive dyskinesia in subjects with schizophrenia or schizoaffective disorder (kinect study)

Conditions: Tardive Dyskinesia

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of nbi-98854 administered once daily for the treatment of tardive dyskinesia (td) symptoms.

this is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety, and tolerability of two doses (50 and 100 mg) of nbi-98854 administered once daily for up to 2 weeks. the study will also allow for an evaluation of the efficacy of nbi-98854 50 mg once daily for up to 6 weeks and the safety and tolerability of nbi 98854 50 mg once daily for up to 12 weeks. the double-blind placebo-controlled treatment period the study has three arms: * nbi-98854 50 mg once daily for 6 weeks * nbi-98854 100 mg once daily for 2 weeks followed by 50 mg once daily for the remaining 4 weeks * placebo at the end of the 6-week placebo-controlled double-blind treatment period, subjects will continue in the study for an additional 6-week open-label period where all subjects who have completed the double-blind treatment period will receive nbi-98854 50 mg once daily. two and four weeks after the last dose of study drug, follow-up assessments will be performed.

Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of schizophrenia or schizoaffective disorder and a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3 months prior to screening. * be receiving a stable dose of antipsychotic medication for a minimum of 30 days before study start. subjects who are not using antipsychotic medication must have stable psychiatric status. * have the doses of concurrent medications and the conditions being treated be stable for a minimum of 30 days before study start and be expected to remain stable during the study. * subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. * female subjects must not be pregnant. * be in good general health and expected to complete the clinical study as designed. * have a body mass index (bmi) of 18 to 38 kg/m2 (both inclusive). * have a negative urine drug screen (negative for amphetamines, barbiturates, benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and study start, except for any subject receiving a stable dose of benzodiazepine. * have a negative alcohol breath test at screening and study start. exclusion criteria: * have an active clinically significant unstable medical condition within 1 month (30 days) prior to screening. * have a history of substance dependence or substance (drug) or alcohol abuse within the 3 months before study start(nicotine and caffeine dependence are not exclusionary). * have a known history of neuroleptic malignant syndrome. * have a significant risk of suicidal or violent behavior. * receiving any excluded concomitant medication such as reserpine, metoclopramide, stimulants, or tetrabenazine. * receiving medication for the treatment of tardive dyskinesia. * have a positive human immunodeficiency virus antibody, (hiv-ab), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) antibody result at screening or have a history of positive result. * have received an investigational drug within 30 days before screening or plan to use an investigational drug (other than nbi-98854) during the study. * have an allergy, hypersensitivity, or intolerance to tetrabenazine. * have had previous exposure with nbi-98854.